None listed
Conditions
Brief summary
The study is complied with ICH-GCP. This is a 2-year prospective, multicenter, randomized treatment trial with a primary objective to test whether glaucomatous eyes (receiving not more than one topical IOP lowering medication at the time of recruitment) with observable progressive LC deformation randomized to additional treatment (IOP reduction) have a greater absolute risk reduction (ARR) of VF (primary outcome measure) and RNFL (secondary outcome measure) progression (i.e. the difference in the proportion of eyes with VF/RNFL progression between the additional treatment and continued treatment groups) compared with those without progressive LC deformation randomized to the same manner. In other words, we expect ARR (LC deformation) > ARR (no LC deformation). Eyes without progressive LC deformation are also randomized because they may also demonstrate further VF progression independent of LC deformation and respond to IOP lowering treatment. The comparison between ARR (LC deformation) and ARR (no LC deformation) will afford an objective measure to quantify the relative treatment effect on eyes with detectable LC deformation.
Interventions
Continued treatment group:
Participants will continue to receive the same treatment started before recruitment. Participants reaching any of the end-points, including VF progression, decrease in VA greater than or equal to 2 lines, and IOP greater than 30mmHg on 2 consecutive follow-up visits in anytime during the study period will be excluded from the study and receive additional treatment, which is the same as the additional IOP lowering treatment group.
Only the investigator (ophthalmologist
Continued treatment group: Participants will continue to receive the same treatment started before recruitment. Participants reaching any of the end-points, including VF progression, decrease in VA greater than or equal to 2 lines, and IOP greater than 30mmHg on 2 consecutive follow-up visits in anytime during the study period will be excluded from the study and receive additional treatment, which is the same as the additional IOP lowering treatment group. Only the investigator (ophthalmologist)will deliver the intervention.
Sponsors
Prof Leung Kai Shun Christopher
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Age 18 years or older 2.Best corrected visual acuity greater than or equal to 20/40 3.POAG patients diagnosed within 12 months without prior history of glaucoma surgical/laser procedure and receiving not more than one topical IOP lowering medication and have been followed up at least 36 months in ongoing study named as “Diagnostic Imaging Assessment in the Evaluation of Glaucomatous Optic Neuropathy and diagnosed with glaucoma “at Hong Kong Eye Hospital'.
Exclusion criteria
IOP >30mmHg measured at any time points during the screening visit; high myopia (spherical error<-6.0D); moderate and advanced VF loss (VF MD <-6dB in the worse eye) or defects close to fixation (any one of the paracentral points with sensitivity <10dB); inability to perform reliable VF; suboptimal quality of SDOCT images (see SDOCT imaging); previous intraocular surgery other than uncomplicated cataract extraction; and diabetic retinopathy/maculopathy.
Outcome results
None listed